A Phase I Study to Evaluate the Safety,Tolerability, Pharmacokinetics, and Efficacy of YL211 in Patients With Advanced Solid Tumors

December 28, 2025 updated by: MediLink Therapeutics (Suzhou) Co., Ltd.

A Phase 1, Multicenter, Open-Label, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of YL211 in Patients With Advanced Solid Tumors

This is a multicenter, open-label, Phase 1 study. The study will enroll subjects with advanced solid tumors. It consists of three parts. Part 1 is dose-escalation part. In part 1, the safety and tolerability of YL211 in patients with selected advanced solid tumors will be evaluated and the MTD and RED will be determined.

Part 2 is backfill enrollment part. We will further estimate the safety and efficacy of YL211 in patients with selected adcance tumor to select the RED(s) of YL211.

Part 3 is dose-expansion part. In this part, we will further evaluate the safety and efficacy of YL211 at the MTD/RED(s) in patients with selected advanced solid tumors YL211 will be administered intravenously (IV) until criteria of treatment discontinuation are met.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
155

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Australia
      • Melbourne, Australia
    • New South Wales
      • Gosford, New South Wales, Australia, 2250
        • Active, not recruiting
        • Gosford Hospital
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Not yet recruiting
        • One Clinical Research - Nedlands
        • Contact:
          • Site Coordinator
  • Canada
      • Ottawa, Canada
        • Not yet recruiting
        • The Ottawa Hospital - General Campus
        • Contact:
        • Principal Investigator:
          • Scott Laurie
    • Toronto
      • Toronto, Toronto, Canada
        • Recruiting
        • Princess Margaret Hospital
        • Principal Investigator:
          • Albiruni Razak
        • Contact:
  • China
      • Chengdu, China
        • Not yet recruiting
        • West China Hospital, Sichuan University
        • Principal Investigator:
          • Yan Zhang
        • Contact:
      • Guangzhou, China
        • Recruiting
        • Sun Yat-sen University Cancer Center
        • Principal Investigator:
          • Ruihua Xu
        • Contact:
        • Sub-Investigator:
          • Danyun Ruan
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100029
        • Recruiting
        • China-Japan Friendship Hospital
        • Contact:
          • Site Coordinator
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310003
        • Recruiting
        • The First Affiliated Hospital - Zhejiang University School of Medicine
        • Contact:
          • Site Coordinator
      • Wenzhou, Zhejiang, China, 325000
        • Recruiting
        • Wenzhou Medical University - The First Affiliated Hospital
        • Contact:
          • Site Coordinator
  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Not yet recruiting
        • University of Colorado Hospital - Anschutz Cancer Pavilion
        • Contact:
        • Principal Investigator:
          • Antonio Jimeno
      • Denver, Colorado, United States, 80218-1238
        • Recruiting
        • Sarah Cannon Research Institute (SCRI) at HealthONE
        • Principal Investigator:
          • Jason Henry
        • Contact:
    • Connecticut
      • North Haven, Connecticut, United States, 06473-2142
        • Recruiting
        • Yale School of Medicine - Yale Cancer Center - Smilow Cancer Hospital Care Centers - North Haven
        • Principal Investigator:
          • Michael Cecchini
        • Contact:
    • Florida
      • Orlando, Florida, United States, 32827
        • Recruiting
        • Sarah Cannon Research Institute at Florida Cancer Specialists
        • Contact:
        • Principal Investigator:
          • Cesar Perez
      • Sarasota, Florida, United States, 34232-6422
        • Recruiting
        • Florida Cancer Specialists & Research Institute (FCS) - Sarasota Cattlemen Office
        • Principal Investigator:
          • Manish Patel
        • Contact:
    • Nevada
      • Las Vegas, Nevada, United States, 89169
        • Active, not recruiting
        • Comprehensive Cancer Centers of Nevada (CCCN) - Central Valley
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Recruiting
        • University of Cincinnati Vontz Center for Molecular Studies
        • Contact:
          • Site Coordinator
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • The University of Texas - MD Anderson Cancer Center
        • Contact:
      • Houston, Texas, United States, 77055
        • Recruiting
        • Next Oncology - Houston
        • Contact:
          • Site Coordinator
      • Irving, Texas, United States, 75039
        • Recruiting
        • Next Oncology - Dallas
        • Contact:
        • Principal Investigator:
          • Shiraj Sen
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • NEXT San Antonio
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Informed of the trial before the start of the trial and voluntarily sign their name and date on the ICF.
  2. Aged ≥18 years.
  3. Be able and willing to comply with protocol visits and procedures.
  4. History of an advanced solid tumors who failed currently available standard therapies and are not amenable to surgical resection, or for whom no available standard therapy or no other approved therapeutic options that have demonstrated clinical benefit.
  5. Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1.
  6. Adequate organ and bone marrow function.
  7. Have at least 1 extracranial measurable tumor lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

Exclusion Criteria:

  1. Inadequate washout period for prior anticancer treatment before the first dose of study drug.
  2. Uncontrolled or clinically significant cardiovascular and cerebrovascular diseases.
  3. Clinically significant concomitant pulmonary disease.
  4. Uncontrolled infection that requires systemic therapy within 2 weeks before the first dose.
  5. Unresolved toxicities from previous anticancer therapy.
  6. A history of severe hypersensitivity reactions to the drug substances, inactive ingredients in the drug product, or other monoclonal antibodies.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Part 1: Dose-Escalation Part
Dose-Escalation Part
Drug: YL211
Patients will be treated with YL211 intravenous (IV) infusion.
Experimental: Part 2: Backfill Enrollment Part
Backfill Enrollment Part
Drug: YL211
Patients will be treated with YL211 intravenous (IV) infusion.
Experimental: Part 3: Dose-Expansion Part
Dose-Expansion Part
Drug: YL211
Patients will be treated with YL211 intravenous (IV) infusion.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
To evaluate nature and frequency of AEs of YL211 in patients with advanced solid tumors according to NCI CTCAE version 5.0
Time Frame: Approximately within 36 months
adverse events (AEs)
Approximately within 36 months
To evaluate nature and frequency of DLTs in part 1.
Time Frame: Approximately within 36 months
dose-limiting toxicity (DLT)
Approximately within 36 months
ORR assessed using RECIST version 1.1
Time Frame: Approximately within 36 months
Objective Response Rate
Approximately within 36 months
To determine the MTD and select the recommended expansion dose(s) (RED(s)) of YL211 in patients with advanced solid tumors
Time Frame: Approximately within 36 months
maximum tolerated dose (MTD)
Approximately within 36 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
To characterize the AUC of YL211 antibody-drug conjugate, YL211 total antibody, unconjugated payload
Time Frame: Approximately within 36 months
area under the curve (AUC)
Approximately within 36 months
To characterize the Cmax of YL211 antibody-drug conjugate, YL211 total antibody, unconjugated payload
Time Frame: Approximately within 36 months
maximum concentration (Cmax)
Approximately within 36 months
To characterize the Ctrough of YL211 antibody-drug conjugate, YL211 total antibody, unconjugated payload
Time Frame: Approximately within 36 months
trough concentration (Ctrough)
Approximately within 36 months
To characterize the Tmax of YL211 antibody-drug conjugate, YL211 total antibody, unconjugated payload
Time Frame: Approximately within 36 months
time of maximum observed concentration (Tmax)
Approximately within 36 months
To characterize the CL of YL211 antibody-drug conjugate, YL211 total antibody, unconjugated payload
Time Frame: Approximately within 36 months
clearance (CL)
Approximately within 36 months
To characterize the Vd of YL211 antibody-drug conjugate, YL211 total antibody, unconjugated payload
Time Frame: Approximately within 36 months
volume of distribution (Vd)
Approximately within 36 months
To characterize the t1/2 of YL211 antibody-drug conjugate, YL211 total antibody, unconjugated payload
Time Frame: Approximately within 36 months
half-life time (t1/2)
Approximately within 36 months
To evaluate the anti-drug immune response after treatment with YL211
Time Frame: Approximately within 36 months
Approximately within 36 months
To evaluate DCR of YL211 in patients with advanced solid tumors using RECIST version 1.1
Time Frame: Approximately within 36 months
disease control rate(DCR, the sum of CR rate, PR rate, and stable disease [SD] rate)
Approximately within 36 months
To evaluate DoR of YL211 in patients with advanced solid tumors using RECIST version 1.1
Time Frame: Approximately within 36 months
duration of response (DoR)
Approximately within 36 months
To evaluate SD of YL211 in patients with advanced solid tumors using RECIST version 1.1
Time Frame: Approximately within 36 months
stable disease(SD)
Approximately within 36 months
To evaluate TTR of YL211 in patients with advanced solid tumors using RECIST version 1.1
Time Frame: Approximately within 36 months
time to response (TTR)
Approximately within 36 months
To evaluate PFS of YL211 in patients with advanced solid tumors using RECIST version 1.1
Time Frame: Approximately within 36 months
progression free survival (PFS)
Approximately within 36 months
To evaluate OS of YL211 in patients with advanced solid tumors using RECIST version 1.1
Time Frame: Approximately within 36 months
overall survival (OS)
Approximately within 36 months
To evaluate percent change in target lesion of YL211 in patients with advanced solid tumors using RECIST version 1.1
Time Frame: Approximately within 36 months
Approximately within 36 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Time Frame
Characterization of genomic alterations that are predictive of response to YL211
Time Frame: Approximately within 36 months
Approximately within 36 months
The use of circulating tumor DNA (ctDNA) to monitor response to YL211 treatment
Time Frame: Approximately within 36 months
Approximately within 36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
MediLink Therapeutics (Suzhou) Co., Ltd.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 7, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 7, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 26, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 22, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 25, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 2, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 28, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • YL211-INT-101-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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